Evidence map›Paper›PMID 28755389›Full record

ArticleDiabetic medicine : a journal of the British Diabetic Association2018

No calcitonin change in a person taking dulaglutide diagnosed with pre-existing medullary thyroid cancer.

S I Sherman, R T Kloos, R M Tuttle, A Pontecorvi, H Völzke, K Harper, C Vance, J T Alston, A L Usborne, K W Sloop and 1 more

Registry-linked trialOpen access · bronzeAbstract readCase Reports
In one paragraph

Article in Diabetic medicine : a journal of the British Diabetic Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00734474. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00734474 phase2 / phase3completed

A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin

Ran2008Enrolled1,202Registered outcomes33Posted comparisons53ConditionsDiabetes Mellitus, Type 2ArmsLY2189265, Metformin, Placebo solution, Placebo tablet, Sitagliptin
Open the trial in the graph
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
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  8. No calcitonin change in a person taking dulaglutide diagnosed with pre-existing medullary thyroid cancer.Diabetic medicine : a journal of the British Diabetic Association · 2018
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 3 countries.

S I ShermanDepartment of Endocrine Neoplasia and Hormonal Disorders, Division of Internal Medicine, University of Texas MD Anderson Cancer Center, Houston, TX.
R T KloosDepartment of Medical Affairs, Veracyte, Inc., South San Francisco, CA.
R M TuttleEndocrinology Service, Memorial Sloan Kettering Cancer Center, New York, NY.
A PontecorviDepartment of Internal Medicine, Catholic University, Rome, Italy.
H VölzkeInstitute for Community Medicine, University Medicine, Greifswald, Germany.
K HarperEli Lilly and Company, Indianapolis, IN.
C VanceRocky Mountain Diabetes and Osteoporosis Center, PA, Idaho Falls, ID, USA.
J T AlstonEli Lilly and Company, Indianapolis, IN.
A L UsborneEli Lilly and Company, Indianapolis, IN.
K W SloopEli Lilly and Company, Indianapolis, IN.
M LakshmananEli Lilly and Company, Indianapolis, IN.ORCID 0000-0002-6578-9570
Eli Lilly (United States) · USMemorial Sloan Kettering Cancer Center · USRocky Mountain Diabetes and Osteoporosis Center · USThe University of Texas MD Anderson Cancer Center · USUniversità Cattolica del Sacro Cuore · ITUniversitätsmedizin Greifswald · DEVeracyte (United States) · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundGlucagon-like peptide-1 receptor agonists, such as dulaglutide, exenatide and liraglutide, are approved to treat Type 2 diabetes mellitus. Although these drugs provide substantial glycaemic control, studies in rodents have prompted concerns about the development of medullary thyroid carcinoma. These data are reflected in the US package insert, with boxed warnings and product labelling noting the occurrence of these tumours after clinically relevant exposures in rodents, and contraindicating glucagon-like peptide-1 receptor agonist use in people with a personal or family history of medullary thyroid carcinoma, or in people with multiple endocrine neoplasia type 2. However, there are substantial differences between rodent and human responses to glucagon-like peptide-1 receptor agonists. This report presents the case of a woman with pre-existing medullary thyroid carcinoma who exhibited no significant changes in serum calcitonin levels despite treatment with dulaglutide 2.0 mg for 6 months in the Assessment of Weekly AdministRation of LY2189265 [dulaglutide] in Diabetes-5 clinical study (NCT00734474). CASE REPORT: Elevated serum calcitonin was noted in a 56-year-old woman with Type 2 diabetes mellitus at the 6-month discontinuation visit in a study of long-term dulaglutide therapy. Retroactive assessment of serum collected before study treatment yielded an elevated calcitonin level. At 3 months post-study, calcitonin level remained elevated; ultrasonography revealed multiple bilateral thyroid nodules. Eventually, medullary thyroid carcinoma was diagnosed; the woman was heterozygous positive for a germline RET proto-oncogene mutation.

conclusionThe tumour was not considered stimulated by dulaglutide therapy because calcitonin remained stable throughout.

Indexed as

CalcitoninCarcinoma, NeuroendocrineDiabetes Mellitus, Type 2Drug SubstitutionFemaleGlucagon-Like PeptidesHumansHypoglycemic AgentsImmunoglobulin Fc FragmentsMiddle AgedProto-Oncogene MasRecombinant Fusion ProteinsThyroid NeoplasmsCalcitonindulaglutideGlucagon-Like PeptidesHypoglycemic AgentsImmunoglobulin Fc FragmentsMAS1 protein, humanProto-Oncogene MasRecombinant Fusion Proteins

Identifiers

PMID28755389
PMCPMC5838554
OpenAlexW2741196883

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.